Super high-flux dialysis filter for restless legs in people on long-term hemodialysis
Tests a super high-flux dialyzer for restless legs syndrome in people receiving hemodialysis.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Super High-Flux Hemodialysis in Maintenance Dialysis Patients. SHINE-RLS (Super High-flux Dialysis Improves Neuro-symptoms and Efficacy in Restless Legs Syndrome)
Key facts
- Where
- New Taipei City, TaiwanSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults on long-term high-flux hemodialysis who have restless legs syndrome. It tests a super high-flux dialyzer against usual high-flux dialysis.
- Age
- 20 years or older
- Sex
- All sexes
- Disease stage
- Restless legs syndrome, diagnosed by standard criteria. On maintenance hemodialysis for kidney failure.
- Earlier treatment
- Must have had maintenance high-flux hemodialysis for at least 3 months, with stable vascular access (AV fistula or AV graft).
- Biomarker or test result
- Dialysis delivery URR ≥ 65% or Kt/V(daugirdes) ≥ 1.2. Serum ferritin ≥ 200 ng/mL and TSAT ≥ 20%.
Main reasons for not taking part
- Low-flux hemodialysis or a temporary catheter
- Serum albumin below 2.5 g/dL
- Hospital stay within the last 4 weeks
- Scheduled kidney transplant
- Active cancer or infection, or pregnancy
This trial only enrols participants on dialysis. The registry sentence this rests on: Maintenance high-flux hemodialysis for ≥ 3 months.
Read by machine on 12 November 2026.
Where in Taiwan
- Far Eastern Memorial HospitalNew Taipei City, TaiwanContact: Wan-Chuan Tsai, M.D., Ph.D.No longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Far Eastern Memorial Hospital
- Trial code
- NCT07794826
- Record updated
- 31 August 2026
- Original description
Patients with end-stage kidney disease (ESKD) rely on maintenance hemodialysis. While high-flux hemodialysis improves small solute clearance, its removal of middle-molecule uremic toxins (e.g., α1-microglobulin [α1-MG]) remains insufficient, contributing to symptoms such as restless legs syndrome (RLS), pruritus, and poor sleep quality, which are also linked to increased cardiovascular risk. In this study, the investigators evaluate whether using a "Super High-Flux" dialyzer (a Type V high-performance dialyzer) during hemodialysis can safely improve the removal of middle-molecule uremic toxins-specifically α1-microglobulin (α1-MG)-and relieve RLS symptoms in maintenance hemodialysis patients.Read full original descriptionShow less
Advancing Dialyzer Technology: Efficacy and Safety of Super High-Flux Hemodialysis in Maintenance Dialysis Patients
Patients with end-stage kidney disease (ESKD) rely on maintenance hemodialysis. While high-flux hemodialysis improves small solute clearance, its removal of middle-molecule uremic toxins (e.g., α1-microglobulin [α1-MG]) remains insufficient, contributing to symptoms such as restless legs syndrome (RLS), pruritus, and poor sleep quality, which are also linked to increased cardiovascular risk. In this study, the investigators evaluate whether using a "Super High-Flux" dialyzer (a Type V high-performance dialyzer) during hemodialysis can safely improve the removal of middle-molecule uremic toxins-specifically α1-microglobulin (α1-MG)-and relieve RLS symptoms in maintenance hemodialysis patients.
Inclusion: Diagnosis of Restless Legs Syndrome according to standard criteria; Age ≥ 20 years; Maintenance high-flux hemodialysis for ≥ 3 months; Stable vascular access (AV fistula or AV graft); Adequate dialysis delivery (URR ≥ 65% or Kt/V(daugirdes) ≥ 1.2); Sufficient iron stores (serum ferritin ≥ 200 ng/mL, TSAT ≥ 20%); Clinically stable condition for the past 4 weeks; Able and willing to comply with study protocol.
Exclusion: Scheduled kidney transplantation; Active malignancy or infection; Any condition impairing protocol adherence; Serum albumin < 2.5 g/dL; Low-flux HD or temporary catheter use; Recent hospitalization (within 4 weeks); Pregnancy.